Catalog Number

460500438

Brand Name

ICU Medical

Version/Model Number

46050-38

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K884318,K884318

Product Code

KRB

Product Code Name

PROBE, THERMODILUTION

Public Device Record Key

5e7b6170-9738-4cff-b9d3-7be4dce1a2e6

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10887709045764

Quantity per Package

10

Contains DI Package

00887709045767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS